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Two similarly designed, placebo-controlled clinical trials are fully accrued and following patients for safety and outcome data.
Unlike previous generations of mAbs, most mAbs currently used in clinical trials are fully human in origin and are produced using either transgenic animals or phage display technology, which helps to reduce immunogenicity, increase effector function, and prolong their serum half-life [9, 52].
However, it is equally important that trials are fully and transparently reported to allow proper critical appraisal by the scientific community.
Our model, however, was based on relative treatment effects (differences between groups expressed as effect sizes 23), and variations in patients' characteristics between trials are fully accounted for in the analysis by maintaining randomised comparisons within each trial.
This phenomenon can significantly affect the generalizability of trials'results, that largely depend upon whether subjects enrolled in clinical trials are fully representative of the entire spectrum of patients suffering from that disease.
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This has led to some trials being fully closed to the public.
Heterogeneity analysis found outcome differences between trials were fully explained by achieved RHR reduction, rather than drug class.
For all experiments, the order of presentation of the trials was fully randomized and different for all subjects.
At the time of analysis, four trials were fully published journal articles, 14, 19, 21, 25) while the rest of the trials were published only in abstract form.
Even so, because commercial trials were fully funded, the potential excess TCs associated with these protocols should not be passed on to commissioners.
However, the likelihood is small since the trials were fully investigator-initiated and data controlled with transparent disclosure of potential conflicts of interest by the respective authors [ 32, 33].
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com